Base Compensation Range: $119,000 - $148,875/yr*In addition, you qualify for:
- Annual bonus opportunity of 15% based on company performance
- Annual equity award of $14,000
Outstanding Benefits and PerksWe are proud to offer a variety of benefits that meet the diverse needs of our employees:
- Eligible for benefits the first day of the month after you start
- Tiered Medical, Dental and Vision Insurance options, Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts
- Company paid short term and long-term disability (unless covered by a state disability plan)
- Company paid life insurance and AD&D
- Flexible Time Off Policy
- Paid sick leave of 48 hours per calendar year
- Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws
- 401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1
- Employee Wellness and Financial Assistance Resources through Cigna and NY Life
- Nine (9) paid company holidays per year
Job SummaryThe Manager, Quality Assurance & Regulatory Affairs is responsible for managing day-to-day Quality Assurance and Regulatory Affairs activities to support product quality, regulatory compliance, and effective execution of the Quality Management System (QMS). This role leads a team of quality and/or regulatory professionals, translates department priorities into operational plans, and ensures assigned quality and regulatory programs are executed consistently and effectively. The Manager partners with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and compliance issues, support product lifecycle activities, and drive continuous improvement.
Duties/Responsibilities- Quality Management Systems & Operations
- Manage the implementation, maintenance, and ongoing effectiveness of assigned elements of the Quality Management System in accordance with applicable standards, regulations, and company requirements.
- Translate quality objectives and department priorities into team goals, work plans, and measurable activities.
- Monitor quality metrics and trends, identify issues, and implement appropriate actions to improve performance.
- Partner with cross-functional teams to ensure quality requirements are incorporated into product lifecycle and operational activities.
- Regulatory Affairs Support
- Manage assigned regulatory activities supporting product development, market access, product changes, and lifecycle management.
- Ensure regulatory activities are completed in accordance with applicable global requirements, standards, and internal procedures.
- Coordinate regulatory submissions, change notifications, registrations, and communications with regulatory bodies as applicable.
- Assess regulatory requirements and provide guidance to cross-functional partners on routine and moderately complex regulatory matters.
- Leadership & People Management
- Lead, coach, and develop Quality Assurance and/or Regulatory Affairs employees, establishing clear priorities, expectations, and accountability.
- Assign work, monitor progress, and balance team resources to meet operational and project requirements.
- Conduct performance discussions, support employee development, and address performance concerns in partnership with Human Resources as appropriate.
- Build team capability through coaching, knowledge sharing, and development opportunities.
- Foster a culture of quality, compliance, collaboration, and continuous improvement.
- Compliance, Audits & Risk Management
- Maintain audit and inspection readiness for assigned areas and support internal and external audits, inspections, and regulatory assessments.
- Coordinate responses to audit observations, nonconformances, and regulatory findings, ensuring actions are completed accurately and on time.
- Identify quality and compliance risks within assigned areas and escalate significant issues as appropriate.
- Support implementation of risk mitigation activities and monitor effectiveness.
- Corrective & Preventive Action (CAPA)
- Manage or support root cause investigations and corrective and preventive action activities for quality and compliance issues.
- Ensure investigations are appropriately documented, actions address identified causes, and commitments are completed within required timelines.
- Monitor CAPA effectiveness and identify recurring issues or trends requiring additional action.
- Partner with cross-functional teams to improve product and process quality and prevent recurrence of quality issues.
- Cross-Functional Collaboration
- Partner with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and regulatory issues and support business objectives.
- Provide practical quality and regulatory guidance for new and existing products, processes, and operational changes.
- Participate in cross-functional projects and ensure quality and regulatory requirements are understood and incorporated into project plans.
- Communicate significant quality, compliance, and regulatory issues to appropriate stakeholders and management.
- Continuous Improvement & Operational Excellence
- Lead or support improvement initiatives within assigned quality and regulatory processes using data and established continuous improvement methods.
- Identify opportunities to improve efficiency, consistency, documentation, and compliance.
- Implement standardized processes and tools that improve team effectiveness and scalability.
- Promote continuous improvement and problem-solving within the team.
- Reporting & Communication
- Prepare and communicate quality and regulatory metrics, trends, risks, and program status to management and cross-functional stakeholders.
- Analyze data to identify trends, support decisions, and recommend actions within assigned areas.
- Maintain clear and timely communication regarding quality events, regulatory activities, project status, and emerging risks.
Experience/Education- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline, or equivalent combination of education and experience.
- Typically 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within a regulated environment.
- Typically 2-3 years of people leadership, supervisory, team lead, or other demonstrated leadership experience.
- Experience working with cross-functional teams and managing multiple quality or regulatory priorities.
Knowledge and Skillsets Required- Strong working knowledge of Quality Management Systems and applicable regulatory compliance frameworks.
- Experience with audits, CAPA, nonconformance management, change control, risk management, and related quality processes.
- Working knowledge of regulatory requirements and product lifecycle activities applicable to the business.
- Demonstrated people leadership skills, including coaching, performance management, prioritization, and team development.
- Strong analytical, problem-solving, and decision-making skills with the ability to resolve moderately complex issues and escalate higher-risk matters appropriately.
- Strong communication and influencing skills with the ability to collaborate effectively across functions and organizational levels.
- Ability to translate department objectives into operational plans, priorities, and measurable team results.
- Strong organizational and project management skills with the ability to manage competing priorities and deadlines.
Physical Demands:- Sitting: Often for extended periods at desks or meetings.
- Standing or walking: Occasionally for meetings, audits, inspections, or office tasks.
- Using computers: Typing and using office equipment.
- Lifting: Light, less than 10 pounds.
- Repetitive motions: Frequent use of keyboard and mouse.
Environmental Conditions:
- Workspace: Climate control (air conditioning or heating) to ensure comfort.
- Lighting: Adjustable lighting to reduce eye strain.
- Noise Levels: The noise level is moderate, with occasional interruptions from phone calls and conversations. Use non-canceling headphones if necessary.
- Ergonomics: Workstations with desk and adjustable chairs to support good postures.
- Ventilation: Good ventilation to ensure a comfortable working environment, though this can vary depending on the building.
